MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number MV-00306HHTA

Device Problems Detachment Of Device Component (1104); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that the embolization coil did not detach with two v-grip controllers.During removal, the coil unexpectedly detached in the microcatheter.The coil was then advanced and implanted in the aneurysm with the delivery wire.There was no reported intervention, patient injury, or health damage.

Manufacturer Narrative

The pusher, introducer, and v-grip controller were returned for analysis.During the investigation, the strain relief was placed on the distal heater coil section, and it appeared burnt, with an irregular non-uniform tip shape.The pusher was noted to be broken at the pet transition.The remainder of the pusher was noted to be within specification, with no kinks or damage.The monofilament within the body coil was analyzed to check on its shape and rebound length; the monofilament appeared to have a stretched tail.Based on the investigation, the reported detachment was confirmed but the analysis showed that the pet was burnt, which is an indication that detachment was attempted, although the coil retaining monofilament appeared to have tensile overload as if an incomplete detachment may have occurred.The returned v-grip was found to be performing to requirements.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7135461
• MDR Text Key: 96038105
• Report Number: 2032493-2017-00338
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350006691
• UDI-Public: (01)04987350006691(11)170830(17)220731(10)17083057C
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: MV-00306HHTA
• Device Lot Number: 17083057C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1